Elavil 10mg recall in Canada: NDMA impurity
In plain language
This recall involves Elavil 10mg tablets sold in Canada. It's being recalled because it exceeds the concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint. Patients can continue to take their medication as prescribed by their health care provider as there is no immediate risk.
What to do
- Contact your health care provider if you have taken a recalled product and have concerns.
- Ask your pharmacist if you are unsure whether you are taking a recalled product.
- Contact Apotex Inc. via Sedgwick at 1-888-266-7914 or apotex5117@sedgwick.com if you have questions.
- Contact AA Pharma at 1-905-669-1565 if you have questions.
- Report any health product-related side effects or complaints to Health Canada.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Elavil FCT 10mg
Lot: PY1830, PY1829
Why this matters
Product safety due to NDMA impurity
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: PY1830, PY1829
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Product safety due to NDMA impurity
What should consumers do?
Contact your health care provider if you have taken a recalled product and have concerns. Ask your pharmacist if you are unsure whether you are taking a recalled product. Contact Apotex Inc. via Sedgwick at 1-888-266-7914 or apotex5117@sedgwick.com if you have questions. Contact AA Pharma at 1-905-669-1565 if you have questions. Report any health product-related side effects or complaints to Health Canada.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Product safety due to NDMA impurity
When was this product recalled?
This product was recalled on January 26, 2022.
Is the Elavil brand affected by this recall?
Yes, Elavil products are affected by this recall. This recall involves Elavil 10mg tablets sold in Canada. It's being recalled because it exceeds the concentration limit for N-nitrosodimethylamine (NDMA) at the 36-month stability testing timepoint. Patients can continue to take their medication as prescribed by their health care provider as there is no immediate risk.